Job Title: Safety & PV Specialist II (MIS)
Updated: October 30, 2025
Location: Gurgaon, Haryana, India
Job ID: 25999948
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By uniting clinical, medical affairs, and commercial expertise, we deliver innovative solutions that address modern healthcare challenges.
Our Clinical Development model places both the customer and the patient at the center of everything we do. We continuously simplify and optimize our processes — making Syneos Health not only easier to work with, but also a great place to work.
With a global team of 29,000+ employees across 110 countries, we have collaborated on:
94% of all FDA-approved novel drugs (past 5 years)
95% of EMA-authorized products
Over 200 studies, spanning 73,000 sites and 675,000+ trial patients
At Syneos Health, WORK HERE MATTERS EVERYWHERE.
Why Join Us
Comprehensive career development and progression opportunities.
Supportive management and dedicated technical & therapeutic training.
Recognition programs and competitive total rewards.
Commitment to our Total Self Culture — a global environment where you can be authentic, valued, and included.
We believe that when diverse perspectives come together, innovation thrives, and everyone feels they belong.
Role Overview
The Safety & PV Specialist II (MIS) will be responsible for supporting pharmacovigilance and drug safety activities across clinical and post-marketing programs. The role requires a detail-oriented professional capable of managing safety data, ensuring compliance with global regulations, and maintaining high-quality standards in case management and safety reporting systems.
Key Responsibilities
Manage and process individual case safety reports (ICSRs) in compliance with global PV regulations.
Conduct data entry, quality review, and reconciliation of safety information.
Support case assessment for seriousness, causality, expectedness, and medical coding.
Ensure timely follow-up and resolution of data discrepancies or missing information.
Contribute to aggregate report preparation, signal detection, and risk management activities.
Collaborate cross-functionally with internal teams to ensure regulatory and operational excellence.
Participate in audits, training, and continuous process improvement initiatives.
Assist in maintaining safety databases and management information systems (MIS) as per SOPs.
Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related field.
Experience in Pharmacovigilance (PV) or Clinical Safety preferred (minimum 2 years for Specialist II level).
Working knowledge of global PV regulations (ICH, GVP, FDA, EMA) and reporting timelines.
Proficiency in safety databases (such as Argus, ArisG, or similar) and MS Office tools.
Excellent attention to detail, analytical thinking, and communication skills.
Ability to work effectively in a fast-paced, global team environment.
Additional Information
Tasks and duties listed are not exhaustive; the company may assign additional responsibilities as required.
Equivalent combinations of education and experience will be considered.
Syneos Health is an equal opportunity employer, committed to diversity, inclusion, and providing reasonable accommodations as per applicable laws.
How to Apply
Interested candidates can apply directly via the Syneos Health careers portal or join our Talent Network to receive updates on future opportunities.
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